SME Assist Help to navigate the regulatory maze Avi Rebera Assistant secretary Regulatory Engagement and Planning Branch ARCS conference, Sydney 8 August 2019
Disclaimer This material is provided to you solely for the purpose of providing a record of what TGA representatives spoke about today. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way. The Australian Government Department of Health (of which the TGA is a part) advises that: a) the papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in this paper. 1
Today’s objectives To provide: • information on TGA’s SME Assist and what the service offers • details on upcoming SME Assist events • information on where to find more help 2
Background • The 2016 review of Medicines and Medical Devices Regulation (MMDR) highlighted that small to medium enterprises (SMEs) can find navigating the ‘regulatory maze’ a challenge • We need to: – make the regulation process easier to understand – provide better support services for SMEs • Consultations were held in 2016 with: – Industry organisations – Government departments 3
SME Assist • Launched 9 June 2017 by the Hon Greg Hunt MP, Minister for Health • Targets the needs of: – SMEs – start-ups – researchers – those unfamiliar with therapeutic goods regulation • Informs therapeutic R&D groups • Assists users to understand their regulatory and legislative obligations 4
Since launch, there has been: 116,000 visitors to the SME Assist web page 424 subscribers to SME Assist emails 32,500 uses of interactive decision tools 241 email enquiries answered 11 ‘Meeting Your Obligations’ workshops held across Australia 643 attendees at workshops 2 educational webinars We have also worked in partnership with: • universities (Flinders, Macquarie, QUT), industry organisations (AusBiotech), research organisations (CSIRO, TRI) and the QLD Government 5
SME Assist 6
Guidance articles • Various introductory topics: – basics of regulation – market authorisation – when to engage with TGA – medical devices overview – useful resources (signposting to other services) • Case studies (e.g. herbalist, importer and researcher) • Information is written in plain English and targeted at beginners 7
Interactive decision tools • Designed to help SMEs and researchers: – better navigate regulatory processes – understand the regulation of specific products • Current interactive tools include: – Is my product a therapeutic good? – What classification is my device? – Which clinical trial scheme should I choose? – What type of GMP application do I require? (manufacturing medicines) – What do I require to have a listed medicine in the ARTG? 8
Phone and email support • Provides tailored and efficient assistance to SMEs and researchers • Enquiries answered directly or forwarded to relevant area Subscription service • Keeps subscribers informed about what’s coming up and what’s new to SME Assist, including: – upcoming workshops, webinars and events – new online resources and tools – news and information relevant to SMEs 9
Upcoming events • Continued rollout of ‘Meeting Your Obligations’ workshops: – Perth (October 2019) – Melbourne and Adelaide (November 2019) – Sydney, Brisbane and Melbourne (2020 - dates to be confirmed) • Addition of new guidance articles and decision tools: – Overview of ingredients – Researcher considerations • Development of further webinars on specific topics • Increased social media presence Subscribe to SME Assist (www.tga.gov.au/sme-assist-email-list) to be notified about dates for upcoming workshops and information about other TGA events 10
Other stakeholder events SME Assist will be providing information sessions at: • Bio Connections Australia Conference, Melbourne August 2019 • ATSA Independent Living Expo, Canberra August 2019 • Bridge Program Symposium, Melbourne October 2019 • GMP Forum, Melbourne November 2019 11
Some key links 12
Separate and distinct products have their own ARTG entry • Every ARTG entry is unique ( separate and distinct ). • This ‘uniqueness’ is defined in a certain way depending on what type of therapeutic good you have. • These definitions can be found in the legislation: Product type Where to look Section Therapeutic Goods Act 1989 Medicines 16 Therapeutic Goods Regulations 1990 Biologicals 11A Therapeutic Goods Act 1989 Medical devices 41BE 13
Australian Regulatory Guidelines Industry > Product type > Standards & guidelines 14
Australian Regulatory Guidelines • All types of therapeutic goods have their own Australian Regulatory Guidelines to assist applicants and sponsors with the process of applying for market authorisation. • Note that these are guidance documents only. ARGCM for complementary medicines ARGOM for over-the-counter medicines ARGPM for prescription medicines ARGS for sunscreens ARGMD for medical devices (currently under review) ARGB for biologicals ARGATG for advertising therapeutic goods (updated) 15
SME Assist www.tga.gov.au/sme-assist 1800 020 653 sme.assist@tga.gov.au 16
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